EL APRENDIZAJE DE LA LECTURA EN LA ESCUELA

Broken experimentation and sham EBPM pose another set of hazards, namely concerns about the ethics of enrolling subjects in futile evaluations. When government-led studies have little payoff—either because they are poorly designed or because the results are highly likely to be neglected or misused in practice—continuing these studies raises ethical questions about enrolling human subjects. Program and policy evaluations themselves (as distinct from policy choices made on the basis of that evidence) may not make subjects worse off than they were before enrolling. But evaluations do burden subjects, and if these burdens cannot be justified by social benefit, these studies may be ethically suspect. This is of particular concern when the experimenter is in fact the government, which exerts multiple forms of coercive power over citizens, exists primarily to promote the long-term well-being and flourishing of its citizens, and enjoys exemptions from some research regulations.214

assumption that a modest wage subsidy is the best that U.S. politics can produce for low-wage workers”).

213. “On matters of deep controversy, research findings are more likely to be mobilised as arrows in the battle of ideas, and sometimes in ways that the original authors may find distasteful.” Head, supra note 23, at 84.

214. Under a change made during the Reagan administration, research subject to an agency head that is designed to evaluate public benefits programs is exempt from IRB review. To What Does this Policy Apply, 45 C.F.R. § 46.101 (2018); Sara Rosenbaum, Weakening Medicaid from Within, THE AM.PROSPECT (Oct. 19, 2017), http://prospect.org/article/weakening-medicaid-within [https://perma.cc/7FAQ-L2HH].

1. Research Lacking Practical Benefits

Research that lacks a practical benefit is categorically unethical under many sources of guidance for research ethics, including the Nuremburg Code,215 _{the Council for International Organizations of Medical Sciences}

guidelines,216 _{the Declaration of Helsinki,}217 _{and the Belmont Report (the}

primary source of guidance in the US).218 _{The rationale for this is threefold.}

First, research of little benefit is more likely to provide an inequitable balance of benefits and burdens. The Belmont Report (and other guidance documents, including the set of federal regulations known as the Common Rule) requires a balancing of the benefits and burdens of research. Participation imposes burdens, even if they are extremely minimal (e.g., a very small risk of a loss of confidentiality, temporary discomfort, or time). Where researchers know in advance that research poses no benefit due to sham EBPM—because it will be misused or neglected, or because it is so deficiently designed that it cannot provide reliable data—then the burdens are likely to outweigh the benefits, tipping the balance closer to unethical research.

Second, individuals who enroll in research (where they do so actively, as compared to simply being followed through administrative data) expect that the study will contribute to knowledge. They may participate for other reasons (e.g., financial incentives, a misconception that research is in fact treatment, or in-kind benefits of participation), but the expectation of contributing to knowledge is a constant, and it becomes part of the “covenant” that researchers and subjects make in the process of informed

215. The Nuremberg Code (1947), 313 BRIT.MED.J. 1448 (1996).

216. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-Related Research Involving Humans (2016).

217. World Medical Association, Declaration of Helsinki (2013), available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical- principles-for-medical-research-involving-human-subjects

[https://perma.cc/YW7D-2VEP].

218. NAT’L COMM’N FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RES.,THE BELMONT REPORT:ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH (1978), https://

www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html [https://perma.cc/BBP6-L66C].

consent.219 _{Where researchers fail to publish or disseminate their results—}

either because they choose not to do so, or because the results are somehow barred from release—they fail to fulfill the promise that subjects’ study participation will contribute to knowledge, thereby undoing the bargain they made with participants.220 _{It is of course possible that researchers may}

publish their findings in good faith, but those findings may be neglected or misused in subsequent policy choices. This happens all the time. But where it is known in advance that the evidence is likely to be distorted, misused, or silenced, or used for ratcheting, it complicates the ethical balancing and should factor into the disclosures that researchers make to subjects in these studies.

Third, the barrier to research that lacks social benefit reflects a concern about policing the boundaries of ethically (and therefore legally) acceptable research. Even if research subjects knew that the results of studies were unlikely to make an impact, or that the study was designed poorly, they may yet consent to take part in the project. But experimentation—particularly medical and governmental research221_{—has an ugly history of abuses in the}

U.S., in service of not only knowledge, but also the prestige and position of researchers. Enrolling subjects in wasted research may exacerbate mistrust of research among U.S. populations that have borne a disproportionate share of these abuses, namely populations that are poor and populations of color. Government-sponsored research with little prospect of social value is especially sensitive in this larger context of government mistrust and experimentation—particularly if the results are later used for ratcheting in ways that harm funding priorities for these groups.

How much practical benefit is necessary? Most research ethics guidance allows wide latitude in determining that research is beneficial. Value could derive from testing programs to identify immediate benefits in health or welfare, from gaining a better understanding of the causes of problems, or

219. Kay Dickersin & Drummond Rennie, Registering Clinical Trials, 290 JAMA 516 (2003).

220. Howard Mann, Research Ethics Committees and Public Dissemination of Clinical Trial Results, 360 LANCET 406 (2002); Richard S. Saver, Medical Research and Intangible Harm, 74 U.CIN.L.REV. 941 (2006); Anna Mastroianni & Jeffrey Kahn, Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research, 31 HASTINGS CTR.REP. 21 (2001).

221. For an introduction to unethical and abusive research practices in the United States, see HARRIET A.WASHINGTON,MEDICAL APARTHEID (2008).

from developing new hypotheses about possible program approaches.222

Assuming a sound research design and public reporting of findings, evaluations that are neglected by regulators and legislators may nonetheless yield important findings that can be used to shape advocacy efforts or enable variations in programs that are decentralized. But where evaluation designs are unsound, or where results are likely to be distorted or used for ratcheting in ways that disadvantage the research participant populations, the ethical benefits of experimentation are unclear and deserve close attention.

Currently there is little oversight over whether research poses social benefits. Federal regulations of human subjects have delegated responsibility for scrutinizing research protocols to institutional review boards (IRBs). IRBs are generally instructed not to consider the long-term consequences of research during protocol review; the Common Rule in fact directs that “in evaluating risks and benefits, the IRB . . . should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those risks that fall within the purview of its responsibility.”223 _{But IRBs do,}

in fact, often consider social implications of research findings despite this rule.224 _{Some have suggested that this is the proper purview of research}

advisory committees instead.225 _{But in the main, it is currently up to}

individual researchers and funders to consider the potential impacts of their research, including the chance that it will exert little effect on policy, or the chance that it will be used for outsized purposes that harm the constituencies in the research population. In areas that are susceptible to sham EBPM, ensuring rigorous research designs and public availability of research results will enable some of the positive externalities described below, even if the findings are ignored or misused at the governmental level.

222. See Ezekiel J. Emanuel et al., What Makes Clinical Research Ethical?, 283 JAMA 2701 (2000).

223. Criteria for IRB Approval of Research, 45 C.F.R. § 46.111 (2018). 224. Alan Fleishman et al., Dealing with the Long-Term social Implications of

Research, 11 AM.J.BIOETHICS 5 (2011); Robert Klitzman, How IRBs View and Make Decisions About Social Risks, 8 J.EMPIRICAL RES.HUM.RES.ETHICS 58 (2013).

2. The Government as Experimenter

When the government is acting as experimenter, either by itself or by contracting with researchers, the ethical basis for experimentation may deserve special scrutiny. Compared to other institutions that conduct and sponsor research, the government possesses greater coercive authority, as well as greater structural obligations to promote the well-being of citizens generally, including those who become research subjects. In some research contexts, our faith that the government will carry out its role to safeguard citizens’ well-being is the basis for wholesale exemptions from independent ethical review of research designs.

The clearest example of this is an exemption embedded as part of the “Common Rule,” the federal regulations providing for institutional review board (IRB) oversight of research with human subjects.226 _{In 1983, the}

Reagan Administration sought to grant a series of Medicaid waivers through § 1115 of the Social Security Act, which allows states a five-year exemption from certain federal regulations in order to implement experimental Medicaid and cash welfare (then AFDC) programming. At the time, the waivers intended to test methods of cost-sharing among the Medicaid population, and were framed in terms of making the programs financially sustainable.227 _{The Carter administration had required separate IRB review} for experimental Medicaid waivers, but Reagan’s HHS quickly reversed this policy. Shortly after the change of administration, HHS implemented changes to the Common Rule with immediate effect,228 _{then issued rules}

specifying that IRB approval would be duplicative and unnecessary for § 1115 waivers. Instead, agency personnel would consider ethics concerns as part of the waiver approval process, which rests on whether a waiver is “likely to advance the purposes” of the Medicaid statute.229 _{As the} administration noted, “ethical and other research problems raised by

226. To What Does this Policy Apply, 45 C.F.R. § 46.101 (2018).

227. Waiver of Requirements as Applied to Medicaid Demonstration Projects Involving Cost-Sharing (Copayments, Deductibles, Coinsurance), 47 Fed. Reg. 9208 (Mar. 4, 1982).

228. Id.

229. Exemption of Certain Research and Demonstration Projects from

Regulations for Protection of Human Research Subjects, 48 Fed. Reg. 9266 (Mar. 4, 1983); see also Lucy A. Williams, The Abuse of Section 1115 Waivers: Welfare Reform in Search of a Standard, 12 YALE L.&POL’Y REV.8(1994); Sara Rosenbaum, Mothers and Children Last: The Oregon Medicaid Experiment, 18 AM.J.L.&MED.97 (1992).

research in benefits programs will be addressed by the officials who are familiar with the programs.”230 _{Recent updates to the Common Rule in}

January 2017 have retained and clarified this exemption from IRB review “in order to make it plain that such research projects on public benefit or service programs [under § 1115 of the Social Security Act] qualify for the exemption.” 231

Separately, a 1992 statutory requirement also specifies that HHS funds may not be used to support research that “poses a danger to the physical, mental, or emotional well-being of a participant without the participant’s informed consent,”232 _{and agencies considering public benefits experiments}

must evaluate research according to this standard. In interpreting the language of the Common Rule, the Ninth Circuit’s 1994 opinion in Beno v. Shalala (along with other courts who have considered the issue) has not challenged the exemption of agency-approved public benefits research from IRB review. Instead, the court noted that the Secretary of HHS was required to “make some determination that a project does not pose unnecessary risks to human subjects” as part of waiver approval, including considering welfare recipients’ objections to proposed waiver plans.

This exemption from IRB review is a departure from ordinary practice for research ethics, but reflects the view that government will seek to prioritize the well-being of the populations it serves, including those that it enrolls in experimental programming and evaluations thereof. Here, the risks to subjects may arise not only from those inherent to the program, but also from how decision-makers are likely to use the evidence produced. Where research is so poorly designed as to be inconclusive, or where it is likely to be used disingenuously for ratcheting or distortion, the ethical basis for this research may be suspect, and it is particularly relevant when the government itself is the party experimenting.